Objective: To compare clinical, functional (Olerud-Molander Ankle Score, OMAS), and radiological outcomes of tension band wiring (TBW) versus malleolar screw fixation in displaced medial malleolar fractures. Methodology: Prospective randomized controlled trial (2022–2025) at Government Medical College, Kadapa enrolled 60 patients (≥18 years, closed displaced transverse/oblique fractures). Randomized 1:1 to TBW (n=30) or malleolar screw (n=30). Outcomes: OMAS (0–100, higher=better), VAS pain (0–10), ankle ROM, radiological union (weeks), complications. Assessed pre/postop, 3/6/9 months. Analyzed by chi-square/t-tests (SPSS). Results: Demographics comparable (age 31–50 years predominant, 75% male, p>0.05). TBW union faster (8.32±1.61 vs 10.69±3.35 weeks, p<0.05). OMAS: TBW 90% good/excellent vs screw 80% (p=0.612). Complications: TBW 10% (2 SSI, 1 skin necrosis) vs screw 6.7% (1 SSI/implant failure/skin necrosis, p=0.399). Mean hospital stay 8.9 days (TBW 8.55±1.90 vs screw 9.25±1.62). Fracture types: SER 57.5%, RTA 40% predominant. No non-unions; full weight-bearing at 6 weeks both groups. Conclusion: TBW achieved faster union with comparable functional outcomes and low complications versus screws, favoring TBW for small/osteoporotic fragments in medial malleolar fractures.
The ankle joint functions as a hinge, transmitting weight from the body to the foot via a mortise-and-tenon structure formed by the distal tibia, fibula, and talus, stabilized by medial/lateral ligaments and syndesmosis.1,2 Ankle fractures comprise ~10% of all fractures, with medial malleolar fractures common in rotational trauma (supination-external rotation [SER] 57.5%, pronation-external rotation [PER] 25%).3,4
Non-displaced fractures (<2mm) succeed with conservative management (cast), but displaced ones risk non-union (periosteum interposition), varus tilt, and posttraumatic arthritis (10–85% if malreduced). 5 Surgical fixation is standard for displaced transverse/oblique patterns to restore mortise stability. 6
Fixation options include tension band wiring (TBW)—converting tensile to compressive forces via eccentric K-wires/18G wire—and malleolar screws (4mm cancellous, lag technique, 90° to fracture). 7,8 TBW excels for small/osteoporotic fragments (dynamic compression); screws provide rigid stability for larger ones (bicortical purchase). 9
Literature shows TBW faster union (8–12 weeks) vs screws (10–16 weeks, p<0.05 biomechanically), comparable OMAS (80–90% good/excellent), low complications (SSI 2–8%).10-12
No Indian RCTs compare both in adults; gaps in union time, cost, osteoporotic bone. 13 This RCT assessed TBW vs screws for union time (primary),
OMAS/VAS/ROM/complications (secondary) in displaced medial malleolus fractures.
OBJECTIVE:
To compare clinical (pain, ROM), functional (Olerud-Molander Ankle Score [OMAS]), and radiological (union time) outcomes of tension band wiring (TBW) versus malleolar screw fixation in displaced medial malleolar fractures.
Study Design and Setting Prospective randomized controlled trial conducted August 2022–December 2024 at Department of Orthopaedics, Government Medical College and General Hospital, Kadapa, Andhra Pradesh, India. Institutional Ethics Committee approved (Ref: GMC/KDP/IEC/2022/045, dated 15/07/2022); CTRI registered (CTRI/2022/08/045123). CONSORT guidelines followed. Informed consent obtained; no funding/conflicts. Participants: Inclusion: Adults (≥18 years), closed displaced (≥2mm) transverse/short oblique medial malleolar fractures (Lauge-Hansen SA/SE/PA/PER). Exclusion: Comminuted/open fractures, polytrauma, pre-existing deformities, pediatric cases. Sample size: 60 (30/group; 80% power, α=0.05, detect 2-week union difference, SD=2.18 weeks). Randomization and Allocation Simple randomization (computer-generated sequence, 1:1 ratio). Sealed opaque envelopes by independent staff. Groups: TBW (n=30), Malleolar screw (n=30). No blinding (assessor blinded for outcomes). Interventions Preop: Spinal anesthesia, supine position, thigh tourniquet post-exsanguination, sterile prep/drape. Surgical technique (anteromedial incision): Fracture exposed, edges freshened, periosteum cleared, reduced (towel clip/reduction forceps). •TBW: Transverse drill hole 2cm proximal tibia; 2 parallel 1.6mm K-wires perpendicular fracture; 18G stainless steel wire figure-8 (threaded hole → under K-wires → tightened); K-wires bent/trimmed/buried. •Malleolar screw: Provisional K-wires; 1–2 4mm partially threaded cancellous screws (superolateral, 90° fracture plane, bicortical far cortex, no joint violation). Postop: Below-knee POP slab (neutral); check dressing/X-rays D2; sutures D12; active ROM D1; NWB crutches 6 weeks; FWB post-union. Outcome Measures Primary: Radiological union (bridging trabeculae ≥3 cortices, AP/lateral/mortise X-rays; weeks to union). Secondary: OMAS (0–100: pain/function/swelling/ROM/walking/support, higher = better); VAS pain (0–10); ankle ROM (goniometer); complications (SSI/skin necrosis/implant failure, Clavien-Dindo Assessments: Baseline, 3/6/9 months (blinded assessor). Statistical Analysis Descriptive (mean±SD, %); chi-square/Fisher's exact (categorical); unpaired t-test (continuous). p<0.05 significant (2-tailed). SPSS v25. Intention-to-treat with LOCF.
|
Characteristic |
TBW (n=30) n(%) |
Screw (n=30) n(%) |
p-value |
|
Age 31–40 years |
20 (66.7) |
20 (66.7) |
>0.05 |
|
Male |
22 (73.3) |
23 (76.7) |
Table 2. Fracture Characteristics
|
Characteristic |
TBW (n=30) n(%) |
Screw (n=30) n(%) |
p-value |
|
Side (Right) |
18 (60.0) |
18 (60.0) |
1.000 |
|
Lauge-Hansen Type |
0.892 |
||
|
- SER |
18 (60.0) |
16 (53.3) |
|
|
- PER |
7 (23.3) |
8 (26.7) |
|
|
- SA |
3 (10.0) |
4 (13.3) |
|
|
- PA |
2 (6.7) |
2 (6.7) |
|
|
Mode of Injury |
0.745 |
||
|
- RTA |
12 (40.0) |
12 (40.0) |
Table 3. Radiological Union Time
|
Parameter |
TBW (n=30) |
Screw (n=30) |
p-value |
Inference |
|
Mean union (weeks) |
8.32 ± 1.61 |
10.69 ± 3.35 |
<0.05 |
TBW significantly faster union |
|
Union <10 weeks (%) |
27 (90.0) |
18 (60.0) |
<0.01 |
TBW superior for early healing |
Unpaired t-test. Inference: TBW dynamic compression accelerates union by ~2.4 weeks (clinically meaningful, reduces immobilization).
Table 4. Functional Outcomes (OMAS at 9 Months)
|
OMAS Category |
TBW (n=30) n(%) |
Screw (n=30) n(%) |
p-value |
Inference |
|
Excellent (90–100) |
16 (53.3) |
14 (46.7) |
0.612 |
Comparable high satisfaction |
|
Good (70–89) |
11 (36.7) |
10 (33.3) |
||
|
Fair (50–69) |
3 (10.0) |
6 (20.0) |
||
|
Mean OMAS Score |
88.2 ± 8.4 |
85.6 ± 10.2 |
0.321<sup>a</sup> |
No significant difference (clinically equivalent) |
Unpaired t-test; Inference: Both achieve excellent/good outcomes (85% overall); TBW nonsignificantly better in fair cases, supporting equivalence for function.